Regulatory Focus™ > News Articles > 2020 > 11 > Asia-Pacific Roundup: Japan’s PMDA asks physicians to cooperate with adverse event relief system

Asia-Pacific Roundup: Japan’s PMDA asks physicians to cooperate with adverse event relief system

Posted 10 November 2020 | By Nick Paul Taylor 

Asia-Pacific Roundup: Japan’s PMDA asks physicians to cooperate with adverse event relief system

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has called for physicians to cooperate with its Relief System for Adverse Drug Reactions. The system, which was set up in 1980, is designed to ensure prompt relief for people who suffer adverse health effects due to properly used drugs.
 
Over its first 39 years in use, the system granted relief to almost 25,000 cases using contributions that marketing authorization holders provided to fulfill some of their social responsibilities. However, while the system is well established, PMDA sees scope to improve its implementation to ensure the prompt provision of relief to everyone who is eligible.
 
PMDA set out the current issues in the November edition of its monthly safety information report. In the report, PMDA presented data to show 30% of the public in Japan have some awareness of the relief system. Less than 10% of people said they were aware of the system. A further 21% of people said they had heard of the system. 
 
“It is inferred that some people may not file an application for compensation for adverse health effects associated with ADRs that they have suffered because they are unaware of the Relief System,” PMDA wrote.
 
Awareness is higher among healthcare professionals. Fifty-nine percent of healthcare professionals were aware of the system, with a further 25% saying that had heard of the system. Awareness of the system was highest among pharmacists and physicians, 97% and 92%, respectively, of whom had at least heard of the relief process. Only 11% of healthcare professionals with awareness of the system had been involved in a filing procedure.
 
The large gap between the awareness among healthcare professionals and the public has led PMDA to seek support with communicating details of the system. PMDA wants healthcare professionals to consider introducing their patients to the relief system. If one of their patients suffers adverse health effects associated with a medicine, PMDA wants healthcare professionals to help prepare medical certificates and other materials needed to seek compensation.
 
PMDA made the request alongside data on what happens after a patient files for relief. In recent years, 82% of applicants have received compensation. The most common reason for non-payment is the inability to confirm a causal role for the drug in the development of the adverse health outcome. PMDA received 1,590 applications for relief last year, down from the recent peak of 1,843 filings in 2016.
 
PMDA Report
 
TGA renames Clinical Trial Exemption scheme
Australia’s Therapeutic Goods Administration (TGA) has renamed the Clinical Trial Exemption (CTX) scheme it uses to permit the study of unapproved therapeutic goods in humans. The scheme is now called the Clinical Trial Approval (CTA) program.
 
TGA originally called the scheme CTX because it exempted sponsors from the need to add products to the Australian Register of Therapeutic Goods (ARTG) before running a clinical trial. TGA now wants to emphasize that sponsors seek its approval to supply unapproved therapeutic goods in Australia.
 
TGA has updated its information and application forms to reflect the change and is asking other agencies and stakeholders to do the same. The scheme is not explicitly mentioned in therapeutic goods legislation so that will remain the same. Only TGA’s online information, application forms and the Australian clinical trial handbook are changing.
 
The Clinical Trial Notification (CTN) scheme is unaffected by the change. Sponsors use CTNs to notify TGA of clinical trials of therapeutic goods that do not require evaluation and entry in the ARTG. It is up to sponsors to decide whether a CTA or CTN is appropriate for their clinical trials.
 
TGA Notice
 
China’s NMPA approves 2 rapid COVID-19 antigen tests
 
China’s National Medical Products Administration (NMPA) has approved two COVID-19 antigen tests that can detect evidence of infection with SARS-CoV-2 within 20 minutes.
 
Early antigen tests fell well short of the accuracy of PCR tests. However, the specificity and sensitivity of antigen tests from Abbott, BD and Quidel now authorized in the US are close to the figures for the far-slower PCR tests.
 
Now, China has approved its first antigen tests. The products were developed by Guangzhou Wondfo Biotech and Beijing Jinwofu Bioengineering Technology. NMPA authorized the antigen tests using an emergency procedure.
 
Like antigen tests authorized in the US, the kits are designed to say whether someone is infected with the coronavirus within 20 minutes. NMPA did not say whether the tests run on instruments, like those sold by BD and Quidel, or are more like Abbott’s pregnancy-style antigen kit. Guangzhou Wondfo, like BD and Quidel, sells fluorescent immunoassay instruments.
 
NMPA said antigen tests should not be relied on to diagnose COVID-19. Rather, results from the tests should be assessed in conjunction with nucleic acid test results, CT imaging and the epidemiologic history.
 
NMPA Notice
 
Pakistan’s DRAP launches adverse event reporting app
 
The Drug Regulatory Authority of Pakistan (DRAP) has introduced a mobile app people can use to share adverse event reports.
 
In 2017, WEB-RADR, a pharmacovigilance initiative supported by the Innovative Medicines Initiative, worked with regulators in Burkina Faso and Zambia to make the Med Safety App available in their jurisdictions. The technology was made available by the UK Medicines and Healthcare products Regulatory Agency (MHRA).
 
Since then, other countries including Ghana, Ivory Coast and Nigeria have adopted the app. DRAP recently revealed Pakistan is the latest country to deploy the app as part of the promotions it ran in relation to the annual #MedSafetyWeek.
 
Use of the app is part of the broader building of pharmacovigilance capacity in Pakistan. In 2017, DRAP established a National Pharmacovigilance Centre. DRAP followed up last year with the release of pharmacovigilance guidance. The National Pharmacovigilance Centre will receive reports uploaded via the app.
 
DRAP Notice
 
TGA fines 2 companies over mask importation
 
TGA has fined Target Australia and Manningham Corporation AU$13,320 ($9,800) for importing face masks that are not included in the ARTG.
 
Early in the pandemic, the Australian government allowed companies to import non-ARTG masks for use in the National Medical Stockpile. The exemption applied to companies that had a contract with the Australian Department of Health, or an agency acting on its behalf, to import personal protective equipment for inclusion in the stockpile.
 
The fines are the latest in a series of punishments TGA has handed out in relation to the importation and promotion of products used in the response to COVID-19.
 
TGA Notice, More
 
Other News:
 
Malaysia’s Medical Device Authority (MDA) has changed the system it provides to enable the public to search for registered medical devices and establishments. The system currently displays search results for licensed establishment data and registered medical devices. MDA Notice

 

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